Kornimate/medical-research-clean huggingface dataset:
prospective registry of targeted radionuclide therapy in patients with mcrpc (reality study)

Conditions: Prostate Cancer Metastatic; Castration Resistant Prostatic Cancer; Advanced Prostate Carcinoma

Summary: this prospective registry aims to assess outcome and toxicity of targeted radionuclide therapies in patients with advanced prostate cancer in clinical routine. while the major investigated treatment modality is prostate-specific membrane antigen (psma)-targeted radioligand therapy, also other radionuclide therapies such as ra223 and liver-directed radioembolization are included. the investigators believe that prospectively assessed long-term outcome data on implementation of radionuclide therapy, especially in the palliative setting of advanced mcrpc, help to better define the real benefits and risks of the respective treatment modalities for patients regarding survival and quality-of-life.

targeted radionuclide therapy is comprised of different modalities that may be applied in advanced prostate cancer, either targeting bone metastases (mainly using radium-223), any site of metastases with psma-expression (ß- / alpha-emitter labelled radioligands) or loco-regionally applying internal radiation (yttrium-90 microspheres) to metastatic liver disease. while in germany, each form of treatment is used in clinical routine, data is sparse regarding the real benefits and risks of respective modalities, also when used in a sequential order. as an example, patients receiving ra223 treatment may later undergo psma targeted radioligand therapy, with little data available on dependent response relationships or cumulative risks. prospective assessment of outcomes and toxicities in a radionuclide therapy registry is apparently superior over retrospective analyses of selected patient populations. the goal of the reality study is to gain a better understanding of the real-life clinical application of radionuclide therapies, with a focus on psma-targeted radioligand therapy in a high-volume treatment centre, and the impact of each treatment for patient outcome. based on primary and secondary outcome measures the potential prediction of treatment benefit by baseline patient and tumor characteristics, and early changes of biomarkers will be of interest.

Eligibility criteria:
inclusion criteria: * signed informed consent form (registry study inclusion form) inclusion criteria for psma rlt: * sufficient tumoral psma expression defined as tracer uptake markedly higher than (physiologic) uptake in healthy liver tissue. * sufficient bone marrow reserve: leukocytes ≥ 2 g/l, platelets \> 75 × 109/l * sufficient overall patient condition: eastern oncology cooperative group (ecog) performance status ≤ 3 exclusion criteria: * inability or unwillingness to provide informed consent

Keywords: mcrpc radioligand therapy psma psma-targeted therapy radionuclide therapy ra-223 bone-targeted radionuclide therapy radioembolization sirt
doppler flow classification of saint-bonnet

Conditions: Peripheral Arterial Disease

Summary: observational study that evaluates the interest of doppler waveforms classification in peripheral artery disease

patients who have doppler ultrasound scanning in clinical practice currently have a systematic record of doppler flow on arterial axes of the aorta and right and left lower limbs. the investigators will analyze a posteriori doppler flow of patients by classifying them using the 3 classifications. the patient will have no constraints related to this study since the recordings are currently performed in clinical routine.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years; * social insured * patients referred in the department for any arterial examination of the lower limbs. exclusion criteria: - patient unfit to understand the instructions of the study
methylphenidate for attention problems after pediatric tbi

Conditions: Traumatic Brain Injury; TBI; ADHD

Summary: traumatic brain injury (tbi) - methylphenidate treatment

the objectives of the study are to (1) determine the efficacy and dose-response of methylphenidate treatment of attention problems after pediatric traumatic brain injury (tbi) and (2) provide a better understanding of the relationship of a prior history of attention deficit hyperactivity disorder (adhd), adhd subtypes after tbi, executive function, and attentional control to treatment efficacy. the proposed clinical trial will enroll 50 children, age 6-17 years, with attention problems \>6 months after moderate to severe tbi into a randomized, double-blind, placebo-controlled, cross-over design trial with 3 dose conditions (low, medium, and high).

Eligibility criteria:
inclusion criteria: * between ages of 6-17 * sustained moderate to severe tbi * tbi occurred at least 6 months prior to beginning the study * tbi occurred no earlier than 5 years of age * positive endorsement of 6 out of 9 items on the vanderbilt adhd inattention or hyperactivity scale exclusion criteria: * history of developmental disability or mental retardation * current active participation in adhd-related behavioral intervention * history of psychiatric condition requiring an inpatient admission in past 12 months * actively taking medications with a contraindication to concerta that cannot be discontinued * current use of stimulant medication or adhd specific medications that cannot be discontinued * non-blunt head injury * family history of arrhythmia * pregnancy

Keywords: tbi traumatic brain injury adhd methylphenidate concerta attention problems
pharmacokinetics, safety and efficacy study of proellex in pre-menopausal women with symptomatic uterine fibroids

Conditions: Uterine Fibroids

Summary: pk of 25 mg and 50 mg proellex® administered once daily (qd) over a 4-month period.

the primary objective is to evaluate the pharmacokinetics (pk) of 25 mg and 50 mg proellex® administered once daily (qd) over a 4-month period.

Eligibility criteria:
inclusion criteria: * female subjects between the ages of 18 and 45 years with body mass index (bmi) between 18 and 35 mg/kg2 inclusive * surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study * subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding * regular or steady menstrual cycle lasting from 24 to 36 days * willing to comply with all study procedures including the endometrial biopsies and pk blood draws for all visits including follow-up visits * subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug exclusion criteria: * documented endometriosis or active pelvic inflammatory disease * history of alcohol and/or drug abuse * any history or diagnosis of gynecological cancer or cervical dysplasia * use of an iud * use of prohibited concomitant medications: * use of depo-provera must cease 10 months prior to first dose of study drug * use of gnrh agonists (e.g., lupron®) must cease 4 months prior to first dose of study drug and lupton® depot 8 months prior to the first visit * known active infection with hiv; hepatitis a, b or c; gonorrhea; or chlamydia

Keywords: uterine fibroids fibroids
oral rehydration therapy for short hydration in chemotherapy with cddp plus gem for biliary tract cancer

Conditions: Biliary Tract Cancer

Summary: the objective of this study is to evaluate the safety and feasibility of oral rehydration therapy for short hydration in patients with biliary tract cancer who will undergo the chemotherapy including gemcitabine and cisplatin.

a large amount of fluid infusion is required to load for the prevention of renal dysfunction by cisplatin in combination of gc therapy. there is a problem infusion time is take a long time for this. in many institutions in japan, gc therapy is performed over 3 hours or more, longer than original method in the abc-002 trial. oral rehydration therapy is a therapy that performs prevention or treatment of dehydration by the ingestion of oral rehydration solution, which is adjusted the concentration of the electrolyte and glucose to absorb good efficiency from the gastrointestinal tract. oral rehydration therapy (ort) is a therapy that performs prevention or treatment of dehydration by the ingestion of oral rehydration solution, which is adjusted the concentration of the electrolyte and glucose to absorb good efficiency from the gastrointestinal tract. many reports suggest ort may substitute for infusion therapy. herein, the investigators planned the study to examine the safety of replacing the fluid infusion by oral rehydration expecting to shorten the time to drip.

Eligibility criteria:
inclusion criteria: 1. patients with histological or cytological diagnosis of biliary tract cancer who haven't received cisplatin previously 2. patients who is planned to receive chemotherapy including gemcitabine and cisplatin for biliary cancer for more than 12 weeks 3. older than 20 years old 4. eastern cooperative oncology group performance status of 0 or 1 5. adequate main organ function 6. fully oral intake ability to drink 500ml of solution before chemotherapy 7. estimated life expectancy no less than 3 months 8. written informed consent - exclusion criteria: 1. patients who received cisplatin previously 2. radiological and clinical evidence of pulmonary fibrosis or interstitial pneumonia 3. patients with uncontrolled diabetes mellitus or severe liver dysfunction or unstable angina or myocardial infarction within 3 months 4. patients with serious infection 5. pregnant or lactating female or patients who wish pregnant 6. patients having severe allergy 7. patients with other serious comorbid diseases 8. patients with severe psychological disease 9. patients with uncontrollable watery diarrhea 10. patients with moderate or severe ascites /pleural effusion 11. patients with severe psychological disease 12. patients who are positive for a test of hepatitis b virus surface antigen (hbs antigen) without controlled with entecavir 13. patients who is judged as an inappropriate case by the investigator -
dysphagia and vocal cord injury following cardiac surgery

Conditions: Dysphagia; Cardiovascular Diseases

Summary: aiming to determine the incidence and contributing risk factors of vocal fold mobility impairment (vfmi) and dysphagia in postoperative cardiovascular patients and evaluate the impact of vfmi on health-related outcomes.

this is a retrospective study to determine: 1. the incidence and contributing risk factors of vocal fold mobility impairment (vfmi) and dysphagia in postoperative cardiovascular patients 2. evaluate the impact of vfmi on health-related outcomes.

Eligibility criteria:
inclusion criteria: * all cardiac surgery patients january 2010-april 2020 at shands hospital * patients aged between 18 and 90 years * undergone an elective, urgent, and/or emergent cardiovascular surgery via endovascular or open (sternotomy and/or extended thoracotomy) technique at the university of florida health. exclusion criteria: * under 18 years old or over 90 years old
mindfulness to mitigate the effect of anxiety-depression-fear in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: people with copd have a greater risk for symptoms of depression, anxiety, and fear of breathlessness. those emotions are independently associated with lower physical activity, poorer quality of life, and higher hospitalization and exacerbations; all independent predictors of survival and costs. there is a lack of treatment options to be routinely used in primary clinics for patients with copd. systematic reviews suggest that interventions that promote an accepting mode of response, such as mindfulness, might be more appropriate and effective for managing psychological distress in copd patients, especially breathing-related anxiety. hypothesis: a home-based 8-week mindfulness-based stress reduction (mbsr) for copd targeted to individuals with symptoms of depression, anxiety, or fear of breathlessness delivered by a mindfulness coach using a combination of in-person sessions and remote video call sessions will be effective in improving emotional and overall quality of life, and measured physical activity.


Eligibility criteria:
inclusion criteria: * lung disease diagnosis * demonstrated competence in proposed technology * current or past smoking status * patient health questionnaire-2 (phq-2) or generalized anxiety disorder scale (gad-2) score \>2 points or answering yes to a validated question of fear of being breathless ("do you experience fear, or panic when you have difficulty getting your breath a good bit of the time?") exclusion criteria: * high likelihood of non-compliance or low confidence using the technology * patients currently in pulmonary rehabilitation * inability to walk * prescribed antidepressant or antianxiety medication within last month * documented substance abuse * cognitive impairment as defined by the mini-mental test score \< 24.
a study to review the treatment and outcomes of teenagers and adults with non-histaminergic angioedema with normal c1 inhibitor in canada

Conditions: Hereditary Angioedema (HAE); Angioedema

Summary: the main aim of this study is to describe the characteristics of participants, check for number of hereditary angioedema (hae) cases, their treatment and outcomes. another aim is to check how the healthcare facilities were utilized for treatment. participants' data will be taken from their medical records (charts), which were already collected as a part of their routine care between january 1, 2012, and january 1, 2022.

this is a non-interventional, retrospective, observational study of participants with hereditary angioedema with normal c1 esterase inhibitor (hae) and non-histaminergic angioedema (nhae) with normal c1-inhibitor function (nc1-inh) receiving various treatments between january 1, 2012, and january 1, 2022. the study will assess case numbers, treatments, outcomes, and healthcare resource utilization in the real-world setting. this study will enroll approximately 90 to 150 participants. participants will be enrolled in the following two cohorts: * participants with hae nc1-inh * participants with nhae nc1-inh this study will have a retrospective data collection from january 1, 2012 to january 1, 2022 by using data from the participant medical charts that were already collected as part of routine care. this multi-center trial will be conducted in canada. the overall time for data collection in this study will be approximately 10 years.

Eligibility criteria:
inclusion criteria: 1. participants ≥12 years of age with hae nc1-inh or nhae nc1-inh diagnosed by an hae treating specialist based on some or all of the following: 1. recurrent angioedema as documented by a healthcare professional within specialist charts 2. normal c4 3. normal c1 level and function 4. condition worsened with estrogen if estrogen is/was being received 5. lack of response to corticosteroid and high-dose regular and/or prophylactic antihistamine(s) treatment(s) 6. family history of non-histaminergic angioedema for patients with hae nc1-inh exclusion criteria: 1. other types of angioedema (type-1 hae, type-2 hae, acquired angioedema, etc.) 2. not meeting the above diagnostic criteria for inclusion 3. response to treatments used for histamine-related angioedema

Keywords: drug therapy
to test the effectiveness of a trained nurse led, m-health enabled intervention to control blood pressure in india

Conditions: Hypertension

Summary: this study evaluates the effect of a mobile health technology enabled trained nurse led intervention on control of blood pressure among patients with hypertension seeking care in the community health centres in the southern state of andhra pradesh, india. half the community health centres will receive the intervention and the other half will receive the routine care.

the burden of hypertension is very high in india but the control rates of hypertension are very low. one of the important reasons for this is the lack of awareness and the inability of the doctors working in busy out patient settings of public health facilities to care adequately for the patients. hence there is a need for task shifting. in this trial a trained nurse care coordinator will be placed in the community health centres (chcs) and she will be provided with an electronic decision support system (edss), in the form of an android application installed on a tablet, to treat hypertension. the trial will be carried out in twelve chcs of visakhapatnam district in southern indian state of andhra pradesh.

Eligibility criteria:
inclusion criteria: 1. participants aged ≥30 years. 2. willing to provide written informed consent for the study. 3. identified as suffering from hypertension (≥160/100 mmhg) with or without co-morbidities such as left ventricular hypertrophy, heart failure, coronary artery disease, peripheral vascular disease, or diabetes mellitus exclusion criteria: 1. participants aged \<30years 2. unwilling/unable to provide written informed consent for the study 3. having malignancies or life threatening conditions 4. currently participating in other clinical trials 5. those with plans to move residence in the year ahead.

Keywords: hypertension high blood pressure task shifting decision support system
in vivo investigation of novel nano-vesicles of salbutamol sulphate

Conditions: Drug Effect; Pulmonary Disease

Summary: the relative bioavailability of different salbutamol sulphate inhaler formulations will be studied in healthy male subjects according to the ethical regulations of world medical association declaration of helsinki (1996) after the approval of the ethical committee, faculty of pharmacy, the british university in egypt.

in this study, 20 healthy, non smoking, adult male volunteers (age: 30-45 years, weight: 65-80 kg) will carry out screening procedures which include instruction and practice with the placebo metered dose inhaler devices that will be used in the study. in addition, all subjects were fully informed in writing of the objectives and implications of the trial. no subject will be considered for the study if developed any symptoms of allergic disorders. subjects will follow a normal diet and will not receive any other medications. volunteers will be divided into two groups; each group contained 10 volunteers who will receive one formula of the selected formulae. each volunteer will inhale eight puffs (4 puffs at -5 min \& 4 puffs at 0 min) which are equivalent to 0.8 mg of salbutamol sulphate . to inhale through metered dose inhalers, volunteers will be trained to exhale slowly to their residual volume (as far as comfortable), put the inhaler into their mouth and seal their lips round the mouth piece. then they will be instructed to take a slow deep inspiration to their total lung capacity over approximately 5-10 seconds. at the end of each inhalation, they will hold their breath for 10 seconds and then breathe normally (ball et al, 2002) . three milliliters of blood will be withdrawn at 0, 0.5, 1, 2, 3, 4, 5 and 6 h after administration. the blood will be heparinized immediately and centrifuged at 3000 rpm for 10 minutes. the plasma samples will be stored at freeze temperature until analysis. two different formulae will be compared during the first six hours following administration. the maximum plasma concentration (cmax), the time required to reach maximum plasma concentration (tmax) and the area under plasma concentration time curve (auc) will be calculated using validated excel software.

Eligibility criteria:
inclusion criteria: * healthy exclusion criteria: * chronic disease * smoking * hospitalization
daily tadalafil and gastric emptying time in diabetic gastroparesis

Conditions: Gastroparesis; Diabetic Gastroparesis; Nausea; Vomiting

Summary: the investigators hypothesize that in adult patients with diabetic gastroparesis with type 1 diabetes (hba1c ≤ 10.5%), daily tadalafil use will significantly improve gastric emptying compared to baseline as measured by gastric emptying time.


Eligibility criteria:
inclusion criteria: * type 1 diabetes diagnosis * age 18 - 65 years (inclusive) * hemoglobin a1c ≤ 10.5% within the last 4 months * diagnosis of gastroparesis, or symptoms consistent with gastroparesis (early satiety, chronic intermittent nausea or vomiting with food intake) * patient has gastroparesis confirmed on screening study * a female patient is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea, or child-bearing potential with negative serum hcg prior to each gastric emptying study. exclusion criteria: * active nitrate use (e.g. cialis, viagra, levitra, nitroglycerin, isordil, imdur, amyl nitrate/poppers) * fasting fingerstick glucose \> 250 mg/dl * history of abdominal surgery including gastric banding procedure * patient is on chronic parenteral feeding * patient has a history of eating disorders (anorexia nervosa, binge eating, bulimia) * regular opiate use * recent (last 6 weeks) history of poor control of diabetes e.g. hypoglycemia requiring medical intervention, diabetic ketoacidosis, admission for control diabetes or complications of diabetes * acute severe gastroenteritis * the patient has participated in another clinical trial in the last 30 days. * use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study \[e.g., prokinetic drugs, macrolide antibiotics (erythromycin), glp-1 mimetics/analog, amylin analog\] * history or presence of clinically significant gastro-intestinal, hepatic or renal disease or other condition that would in the opinion of the investigator make the subject unsuitable for inclusion in this clinical study. * chronic angina or nyha class iii or iv chf * concurrent use of ketoconazole or itraconazole * history of severe vision loss, retinitis pigmentosa, or non-arteritic anterior ischemic optic neuropathy (naion) * history of cva * pregnant females as determined by positive serum hcg test * lactating females * uncontrolled hypertension (sbp \> 160 or dbp \> 100) * hypotension (sbp \< 90 or dbp \< 60) * other major medical conditions: priapism, sickle cell anemia, multiple myeloma, leukemia, active cancer diagnosis, hiv/aids, alcoholism, or bleeding diathesis. * intolerance to active or inactive ingredients of cialis, or intolerance to other pde-5 inhibitors.

Keywords: gastroparesis gastric emptying diabetes stomach diseases gastrointestinal diseases digestive system diseases phosphodiesterase inhibitors neurologic manifestations paralysis signs and symptoms pharmacologic actions